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Neurodevelopment After Early Iron Supplementation

U

University of Ulm

Status

Completed

Conditions

Anemia of Prematurity
Iron Deficiency
Neurodevelopmental Delay

Treatments

Drug: Oral administration of ferrous sulphate

Study type

Interventional

Funder types

Other

Identifiers

NCT00457990
UL-NEO-IRON-2

Details and patient eligibility

About

Background: Iron deficiency in early childhood may impair neurodevelopment.

Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants.

Method: Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the time of school entry.

Full description

Children with a birth weight of < 1301g who participated in a randomized controlled trial of early versus late enteral iron supplementation were evaluated applying a standardized neurological evaluation, the Kaufmann Assessment Battery for Children, and the Gross Motor Function Classification Scale (GMFCS) at the age of school entry.

Severe disability was defined as any of the following: any abnormal neurological examination associated with a severely impaired mobility (GMFCS>1), severe cognitive impairment (mental processing composite (MPC) <51), hearing loss requiring amplification, or blindness. The absence of disability was defined as normal neurological examination, normal mobility (GMFCS=0), and normal cognitive development (MPC>85) and the absence of any severe hearing and visual impairment.

Sex

All

Ages

4 to 7 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • inborn infants with a birth weight of <1301g admitted between June 1996 and June 1999

Exclusion criteria

  • major anomalies, hemolytic disease, twin-to-twin transfusion syndrome, missing parental consent

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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